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Scientists track Drug's journey in healthy men

NCT ID NCT01702194

Knowledge-focused Sponsor: Glycyx Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how the body processes TD-1211, a drug for opioid-induced constipation. Ten healthy men received a single dose of the drug with a radioactive tracer to track its absorption, distribution, and elimination. The goal was to understand the drug's behavior, not to treat any condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Start date

Nov 2012

Finished

Mar 2013

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy, nonsmoking male, 18 to 50 years old, inclusive. 2. Agrees to use a highly effective method of birth control. 3. Body mass index (BMI) 19 to 30 kg/m2, inclusive, and weighs at least 55 kg. 4. Willing and able to give written informed consent. Exclusion Criteria: 1. Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. 2. Hemoglobin \<14.1 g/dL or hematocrit \< 40.6% at Screening. 3. History of hypersensitivity to drugs, or a history of or any current clinically significant hypersensitivities. 4. Any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\]). 5. Participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).

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Conditions

The condition(s) this trial relates to.

constipation disorder opioid-induced constipation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OIC

Contacts and locations

Locations

  • Covance

    Madison, Wisconsin, 53704, United States

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